angiOCCLUDE Ligating Clips— 510(k) K230966
Substantially EquivalentA2 Medical Systems, LLC
FDA 510(k) clearance K230966 for angiOCCLUDE Ligating Clips, Substantially Equivalent on 2023-09-19. Applicant: A2 Medical Systems, LLC.
Clearance details
- Applicant
- A2 Medical Systems, LLC
- Product code
- Code FZP
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kalamazoo, MI, US
Adverse events under product code FZP
product code FZP- Death
- 11
- Injury
- 726
- Malfunction
- 10,830
- Other
- 1
- Total
- 11,568
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.